- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07275411
mHealth App for Oral Hygiene and Cancer Awareness in Older Adults
Tele-education Through a New Mobile Application to Improve Oral Cancer Knowledge and Oral Hygiene in Older Adults
The goal of this clinical trial is to learn whether a mobile app with educational videos and serious games is more effective than a video-only version of the app to improve knowledge, attitudes, and practices about oral cancer and oral hygiene in older adults.
The study also aims to evaluate the usability of the app and the impact of the intervention on performing oral self-examination.
The main questions it aims to answer are:
- - Does the version of the app with videos and serious games lead to greater improvement in oral cancer knowledge than the video-only version?
- - Are there differences in attitudes and self-examination practices between the two groups after using the app?
- - How frequently and consistently do participants use the app during the study period, and how much do they interact with the educational videos and serious games?
- - Are there differences in outcomes by sex or education level?
Participants will:
Be adults aged 60 and more receiving care at the Dental Clinic of the University of Chile
Be randomly assigned to use one of two versions of the same app:
- Group A: Access to educational videos and serious games
- Group B: Access to educational videos only
Use the app for 4 weeks
Answer a questionnaire before starting, after 2 weeks, and after 4 weeks
Perform an oral self-examination at week 4, which will be evaluated using a checklist
This trial will help determine whether mobile tele-education tools, especially those that include interactive features like serious games, are effective and acceptable ways to improve oral health education in older adults.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Santiago, Chile
- Dental Clinic, Faculty of Dentistry, University of Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 60 years and older.
- Completed dental treatment at the Dental Clinic of the Faculty of Dentistry, University of Chile, during 2023 and 2024.
- Own a smartphone with Android operating system.
- Regular users of at least one social media platform (e.g., WhatsApp, Instagram, Facebook).
Exclusion Criteria:
- Older adults with self-reported uncorrected visual or auditory sensory deficits resulting in total blindness or deafness.
- Older adults with cognitive impairment, defined as a score of 13 or lower on the abbreviated Mini-Mental State Examination (MMSE) (maximum score 19).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Serious Games Group
Participants receive an oral health mobile application with educational videos and serious games designed to improve knowledge and self-examination practices.
|
This intervention consists of a mobile application designed to improve oral health knowledge, attitudes, and practices among older adults.
The app includes educational videos about oral hygiene and oral cancer.
In the experimental group, the app also incorporates interactive serious games to reinforce learning and promote oral self-examination.
In the active comparator group, participants have access only to the educational videos within the same app.
The intervention targets individuals aged 60 to 70 years and is evaluated over a 4-week period through questionnaires and observation of oral self-examination practices.
|
|
Active Comparator: Video-Only Group
Participants receive an oral health mobile application with educational videos only, without interactive components.
|
This intervention consists of a mobile application designed to improve oral health knowledge, attitudes, and practices among older adults.
The app includes educational videos about oral hygiene and oral cancer.
In the experimental group, the app also incorporates interactive serious games to reinforce learning and promote oral self-examination.
In the active comparator group, participants have access only to the educational videos within the same app.
The intervention targets individuals aged 60 to 70 years and is evaluated over a 4-week period through questionnaires and observation of oral self-examination practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge, attitudes about oral cancer and oral hygiene, and performance of oral self-examination in older adults using a mobile educational application.
Time Frame: Baseline, 2 weeks, and 4 weeks after the start of the intervention.
|
increasing participants' knowledge and attitudes regarding oral cancer and oral hygiene, as well as their ability to perform oral self-examination.
Knowledge and attitudes are measured using a structured questionnaire administered at baseline, 2 weeks, and 4 weeks.
Oral self-examination practices are evaluated at 4 weeks using a standardized checklist verifying the correct performance of five key steps.
Comparisons are made between the group using videos and serious games and the group using videos only.
|
Baseline, 2 weeks, and 4 weeks after the start of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usability of the mobile oral health education application
Time Frame: 4 weeks
|
Evaluates participant use and engagement with the mobile app by analyzing interaction logs recorded within the app over the 4-week intervention period.
Usage data are compared between the group using videos plus serious games and the group using videos only.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Iris Lucia Espinoza-Santander, PhD in Public Health, Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of Chile
- Study Chair: Constanza Beatriz Morales-Gómez, Master's Degree in Science, Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of Chile
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIES009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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